1. Field of the Invention
The present invention relates to a novel composition for the injection of active type vitamins D.sub.3. More specifically, the present invention relates to a composition for the injection of active type vitamins D.sub.3 comprising a lyophilized product of active type vitamins D.sub.3 and an excipient.
2. Description of the Related Art
Active vitamins D.sub.3 such as 1.alpha.-hydroxycholecalciferol, 1.alpha.,25-dihydroxycholecalciferol, 1.alpha.,24-dihydroxycholecalciferol, etc., have functions to accelerate the absorption of calcium through the small intestine and also promote the resorption of calcium from the bone and accordinlgy they are useful as a remedy for treating such diseases as osteoporosis, osteomalacia, rickets, etc.
However, these active type vitamins D.sub.3 are all unstable to heat and light, and also susceptible to oxidation, and therefore, a stable preparation thereof is desired.
In the prior art, as the preparations of these active type vitamins D.sub.3, preparation forms for oral administration such as soft capsules having active type vitamins D.sub.3 dissolved in medium chain fatty acid triglycerides (see Japanese Unexamined Patent Publication (Kokai) No. 53-26316), tablets, hard capsules, etc , comprising compositions of active type vitamins D.sub.3 and polyvinylpyrrolidone (see Japanese Unexamined Patent Publication (Kokai) No. 58-206533) are known.
In recent years, the necessity for administering these active type vitamins D.sub.3 as injection preparations to patients suffering from cancer, etc., requiring a large amount of active type vitamins D.sub.3, old people, or patients to whom oral administration is not adequate because of digestive tract abnormality, bile duct obliteration or stomach ablation, etc., has been recognized.
In the prior art, as the injection preparation of active type vitamins D.sub.3, aqueous injection preparations having active type vitamins D.sub.3 solubilized together with antioxidants, chelating agents, etc., have been known (c.f. Japanese Unexamined Patent Publication (Kokai) No. 57-144218, which corresponds to U.S. Pat. No. 4308264). However, this method has a cumbersome preparation process, and requires a high technique for the preparation and the stability of the active type vitamins D.sub.3 in the aqueous injection preparation is insufficient. Therefore, it cannot be said to be a useful preparation. Accordingly, there is a need to develop an injection preparation of active type vitamins D.sub.3 which can be easily prepared and has a good stability.